APPLICATION
ANDA214182
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-11
LATEST ACTION
2024-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EVEROLIMUSPrescription
EVEROLIMUS 10MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 5MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 7.5MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 2.5MG · TABLET · ORAL
Approval history
2024-04-09Labeling · Supplement 10 · standardAP
2023-02-24Labeling · Supplement 4 · standardAP
2023-02-24Manufacturing (CMC) · Supplement 7 · unknownAP
2021-02-11UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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